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Name of the ingredient
Hesperidin (AAN)
Definition of the ingredient
(S)-7-[[6-O-(6-Deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-2,3-dihydro-4H-1-benzopyran-4-one
Molecular formula: C28H34O15
Molecular mass: 610.56
CAS Number: 520-26-3
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | Pale yellow - yellow green crystalline, hygroscopic powder |
| Solubility | BP (General notice) | Slightly soluble in water and methanol, soluble in solutions of alkali hydroxides |
| Melting point | BP (Appendix V A) | 258-262°C |
| Optical rotation | BP (Appendix V F) | -74° to -78° (in pyridine), calculated with reference to the dried substance |
| Water (determined on 0.100g) | BP (Appendix IX C, method 1) | Not more than 5.0% w/w |
| IR | BP (Appendix II A) | Spectrum matches that of the authenticated reference material |
| Hesperidin | HPLC | 98.0-102.0% (anhydrous basis) |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Incidental metals and non-metals | ||
| Other organic or inorganic impurities or toxins | ||
| Microbiology | ||
| Residual solvents | BP (Appendix VIII L) | Complies |
| Heavy metals (as lead) | BP (Appendix VII) | Not more than 10 ppm |
| Sulfated ash | BP (Appendix IX A) | Not more than 0.4% |
| Related substances | HPLC | Not more than 1.0% for oxedrine or any other individual impurity, and not more than 2.0% for total impurities |
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' - external site mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
Key to abbreviations
BP = British Pharmacopoeia
HPLC = High-pressure liquid chromatography
IR = Infrared spectrophotometry